MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE SKYPOINT¿; CORONARY DRUG-ELUTING STENT

Model Number	1804400-15
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the procedure was to treat a heavily calcified and mildly tortuous lesion in the left anterior descending artery.The lesion was pre-dilated with a 3.0mm balloon, followed by ivus to confirm calcification.After atherectomy was performed, the 4.0x8mm nc trek neo balloon dilatation catheter (bdc) was advanced to the target lesion however the balloon ruptured at 11 atmospheres (atm).A 4.0x15mm xience skypoint stent was deployed; however, the stent was not well apposed to the vessel wall due to the calcification.An additional 4.0x15mm xience stent was inflated to 15 atm without issues, completing the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
The device was not returned for analysis.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the information provided, a definitive cause for the reported issue could not be determined; however, the reported treatment appears to be related to operational context of the procedure.Based on the results of the complaint investigation, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported the procedure was to treat a heavily calcified and mildly tortuous lesion in the left anterior descending artery.The lesion was pre-dilated with a 3.0mm balloon, followed by ivus to confirm calcification.After atherectomy was performed, the 4.0x8mm nc trek neo balloon dilatation catheter (bdc) was advanced to the target lesion however the balloon ruptured at 11 atmospheres (atm).A 4.0x15mm xience skypoint stent was deployed; however, the stent was not well apposed to the vessel wall due to the calcification.An additional 4.0x15mm xience stent was inflated to 15 atm without issues, completing the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SKYPOINT¿
• Common Device Name: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary UNK ; EI UNK
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 24038891
• Report Number: 2024168-2026-00211
• Device Sequence Number: 18456735
• Product Code: NIQ
• UDI-Device Identifier: 08717648233470
• UDI-Public: (01)08717648233470(17)260809(10)3081541
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/09/2026
• Device Model Number: 1804400-15
• Device Catalogue Number: 1804400-15
• Device Lot Number: 3081541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown